Formulation and Manufacturing Method for Color-Changing Eyedrops

Abstract

Disclosed is a formulation and a manufacturing method for color-changing eyedrops.

What is claimed is: 
     
         1 . A formulation for color-changing eyedrops comprises:
 a quantity of active ingredients;   a quantity of isotonic solution;   the quantity of active ingredients comprises a quantity of N-Acetyl Glucosamine (NAG), at least one quantity of ophthalmic lubricant, a quantity of potassium bicarbonate, a quantity of boric acid, and a quantity of preservative; and   the quantity of active ingredients and the quantity of isotonic solution being homogeneously mixed into an ophthalmic mixture.   
     
     
         2 . The formulation for color-changing eyedrops as claimed in  claim 1 , wherein the quantity of active ingredients approximately ranges between 4.1 weight percent (wt. %) to 5.1 wt. % of the ophthalmic mixture. 
     
     
         3 . The formulation for color-changing eyedrops as claimed in  claim 1 , wherein the quantity of isotonic solution is sterile water. 
     
     
         4 . The formulation for color-changing eyedrops as claimed in  claim 3 , wherein a pH level of the quantity of isotonic solution is approximately 6.4. 
     
     
         5 . The formulation for color-changing eyedrops as claimed in  claim 1 , wherein the quantity of NAG approximately ranges between 24.3 wt. % to 39.1 wt. % of the quantity of active ingredients. 
     
     
         6 . The formulation for color-changing eyedrops as claimed in  claim 1  comprises:
 the at least one quantity of ophthalmic lubricant comprises a quantity of carboxymethylcellulose sodium; and 
 the quantity of carboxymethylcellulose sodium approximately ranging between 5.9 wt. % to 7.3 wt. % of the quantity of active ingredients. 
 
     
     
         7 . The formulation for color-changing eyedrops as claimed in  claim 1  comprises:
 the at least one quantity of ophthalmic lubricant comprises a quantity of glycerin; and 
 the quantity of glycerin approximately ranging between 19.6 wt. % to 24.3 wt. % of the quantity of active ingredients. 
 
     
     
         8 . The formulation for color-changing eyedrops as claimed in  claim 1 , wherein the quantity of potassium bicarbonate approximately ranges between 19.6 wt. % to 24.3 wt. % of the quantity of active ingredients. 
     
     
         9 . The formulation for color-changing eyedrops as claimed in  claim 1 , wherein the quantity of boric acid approximately ranges between 9.8 wt. % to 12.2 wt. % of the quantity of active ingredients. 
     
     
         10 . The formulation for color-changing eyedrops as claimed in  claim 1  comprises:
 the quantity of preservative being purified benzyl alcohol; and 
 the quantity of preservative approximately ranging between 6.1 wt. % to 7.6 wt. % of the quantity of active ingredients. 
 
     
     
         11 . A method of manufacturing color-changing eyedrops, the method comprises the steps of:
 (A) providing a quantity of NAG, at least one quantity of ophthalmic lubricant, a quantity of potassium bicarbonate, a quantity of boric acid, a quantity of preservative, and a quantity of isotonic solution;   (B) formulating a first intermediate solution by homogeneously mixing the at least one quantity of ophthalmic lubricant, the quantity of potassium bicarbonate, the quantity of boric acid into the quantity of isotonic solution;   (C) autoclaving the first intermediate mixture at a specified temperature and pressure for a specified period of time;   (D) formulating a second intermediate solution by homogeneously mixing the quantity of NAG into the first intermediate solution; and   (E) formulating an ophthalmic mixture by homogeneously mixing the quantity of preservative into the second intermediate mixture;   (F) sequentially executing steps (B) through (E).   
     
     
         12 . The method of manufacturing color-changing eyedrops, the method as claimed in  claim 11  comprises the step of:
 separately mixing the quantity of boric acid, the quantity of ophthalmic lubricant, and the quantity of potassium bicarbonate into the quantity of isotonic solution, while continuously stirring the quantity of isotonic solution during step (B). 
 
     
     
         13 . The method of manufacturing color-changing eyedrops, the method as claimed in  claim 11 , wherein the specified temperature and pressure are 121° Celsius (C) at 12 pounds per square inch, and wherein the specified period of time is 45 minutes. 
     
     
         14 . The method of manufacturing color-changing eyedrops, the method as claimed in  claim 11  comprises the step of:
 cooling the first intermediate solution at a cooler temperature after step (C), wherein the cooler temperature approximately ranges between 30° C. to 40° C. 
 
     
     
         15 . The method of manufacturing color-changing eyedrops, the method as claimed in  claim 11  comprises the step of:
 filtering the first intermediate solution with a first membrane filter in between steps (C) and (D). 
 
     
     
         16 . The method of manufacturing color-changing eyedrops, the method as claimed in  claim 15 , wherein the first membrane filter is a 0.45 micron NN type 293 mm diameter. 
     
     
         17 . The method of manufacturing color-changing eyedrops, the method as claimed in  claim 11  comprises the step of:
 filtering the second intermediate solution with a second membrane filter in between steps (D) and (E). 
 
     
     
         18 . The method of manufacturing color-changing eyedrops, the method as claimed in  claim 17 , wherein the first membrane filter is a 0.22 micron NN type 293 mm diameter. 
     
     
         19 . The method of manufacturing color-changing eyedrops, the method as claimed in  claim 11 , wherein the step (E) is executed over a duration of 10 minutes.